# K100156: Collagen Dental Membrane V

- Pathway: 510(k) (Traditional)
- Applicant: Collagen Matrix, Inc.
- Decided: Aug 11, 2010 after 203 days
- Product code: NPL (Barrier, Animal Source, Intraoral)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K924408 (1995). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090216: Collagen Dental Membrane IV, Collagen Matrix, Inc. (2009) Summary page 1.
- K050446: Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone, Ed. Geistlich Soehne AG Fuer Chemische Industrie (2005) Summary page 1.

## Most influential descendants
- K141909: Collagen Dental Membrane - Conformable PP (2014), 0 descendants of its own

## Recalls of this device
- Nov 5, 2019 · Class II · Z-0908-2020: The products may have been packaged with an incorrect Instructions for Use.
- Nov 5, 2019 · Class II · Z-0910-2020: The products may have been packaged with an incorrect Instructions for Use.
- Nov 5, 2019 · Class II · Z-0909-2020: The products may have been packaged with an incorrect Instructions for Use.
- Nov 5, 2019 · Class II · Z-0911-2020: The products may have been packaged with an incorrect Instructions for Use.
- Nov 5, 2019 · Class II · Z-0912-2020: The products may have been packaged with an incorrect Instructions for Use.
- Nov 5, 2019 · Class II · Z-0907-2020: The products may have been packaged with an incorrect Instructions for Use.

## Indications for use
Collagen Dental Membrane V is intended for use in oral surgical procedures as a resorbable membrane material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.

Source page: https://510kreport.com/device/K100156
Methodology: https://510kreport.com/methodology